By Maria Christofidou, i~HD Early Stage Researcher

The European Commission has, since the introduction of the General Data Protection Regulation (GDPR), made efforts towards the implementation of policies and regulations which are fit for the digital age while also ensuring trustworthy and safe use and reuse of data. Some examples that can act as testaments to this include the recent adoption of the Data Governance Act (‘DGA’) by the responsible European Parliament committee, the White Paper on Artificial Intelligence (AI) and the Proposal on AI as well as the Proposal on Data Governance Act, all of which can be interconnected when it comes to data use and/or reuse in the field of innovation in healthcare.  

The DGA is the first of a set of measures announced in the 2020 European strategy for data and offers a new form of data governance through the establishment of an alternative model to the data-handling practices of the big technology platforms. An aspect of this model is the provision of a framework for sharing data on “altruistic grounds” stating that individuals and organisations can engage in data altruism. The DGA overall aims to better exploit the potential of ever-growing data in a trustworthy European framework and keeps the GDPR as one of its integral parts. Similarly, the Proposal on AI provides a novel legal framework, both of which aim to guarantee safe and trustworthy use of data and AI while promoting innovation in the EU.

The Proposal introduces new oversight for “high-risk” AI systems, a light-touch approach towards obligations for low-risk AI systems, and a new system of enforcement on Member State and at the EU level. Although questions remain on various fields address by the Proposal, the European Data Protection Board has recently provided guidance and clarity in the interconnection of the Proposal with the GDPR and data protection, stressing the important role that data protection and privacy implications play. Whilst the Proposal is still in its infancy and the DGA is to proceed for inter-institutional negotiations between the Parliament and the Council, they both will inevitably affect all sectors of the European Union and its economy, which by extension places obligations onto companies and Member States to be compliant with the Proposal, the DGA, the GDPR, and other European and national regulations and laws where necessary. 

i~HD GDPR Webinars

Our 2021 GDPR webinar Programme is designed to help you understand these novel sectors of data sharing, data governance, and AI.

Through i~HD’s group of leading experts, varying from clinical academics and practitioners to lawyers, ICT experts, Regulatory Experts, and our industrial and patient representative communities, we’re able to provide tailored answers to your questions and help you navigate these interconnecting fields. Whether these are questions you may have surrounding information governance, data protection, and innovation through health data use and reuse, we’re here to help – we look forward to welcoming you.

Maria Christofidou

Maria Christofidou

i~HD Early Stage Researcher